Pharmacogenomics decision support in the U-PGx project: Results and advice from clinical implementation across seven European countries

Background The clinical implementation of pharmacogenomics (PGx) could be one of the first milestones towards realizing personalized medicine in routine care. However, its widespread adoption requires the availability of suitable clinical decision support (CDS) systems, which is often impeded by the fragmentation or absence of adequate health IT infrastructures. We report results of CDS implementation in the large-scale European research project Ubiquitous Pharmacogenomics (U-PGx), in which PGx CDS was rolled out and evaluated across more than 15 clinical sites in the Netherlands, Spain, Slovenia, Italy, Greece, United Kingdom and Austria, covering a wide variety of healthcare settings. Methods We evaluated the CDS implementation process through qualitative and quantitative process indicators. Quantitative indicators included statistics on generated PGx reports, median time from sampled upload until report delivery and statistics on report retrievals via the mobile-based CDS tool. Adoption of different CDS tools, uptake and usability were further investigated through a user survey among healthcare providers. Results of a risk assessment conducted prior to the implementation process were retrospectively analyzed and compared to actual encountered difficulties and their impact. Results As of March 2021, personalized PGx reports were produced from 6884 genotyped samples with a median delivery time of twenty minutes. Out of 131 invited healthcare providers, 65 completed the questionnaire (response rate: 49.6%). Overall satisfaction rates with the different CDS tools varied between 63.6% and 85.2% per tool. Delays in implementation were caused by challenges including institutional factors and complexities in the development of required tools and reference data resources, such as genotype-phenotype mappings. Conclusions We demonstrated the feasibility of implementing a standardized PGx decision support solution in a multinational, multi-language and multi-center setting. Remaining challenges for future wide-scale roll-out include the harmonization of existing PGx information in guidelines and drug labels, the need for strategies to lower the barrier of PGx CDS adoption for healthcare institutions and providers, and easier compliance with regulatory and legal frameworks.

3. Since January 2017, have you at least once used the following methods to view or interpret a patient's pharmacogenomic test results? * Please select "Digital pharmacogenomic report via the electronic health record" for all cases in which you retrieved pharmacogenomic results and recommendations via the electronic health record but not via an automatic alert.
The safety-code card is a pocket card that contains an overview about the patient's pharmageonomic profile and a QR code that, after scanning, takes the user to patientspecific pharmacogenomic recommendations.

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Must be numeric Hidden unless: #2 Question "Since January 2017, have you at least once ordered a pharmacogenomic test for a patient?" is one of the following answers ("Yes") Shortname / Alias: Number of tests Variable name: Number of tests 13 4. On average, how many pharmacogenomic tests do you order per week, approximately? * Hidden unless: Question "Other method(s)" is one of the following answers ("Yes") Shortname / Alias: OM Variable name: OM 47 5. Please specify the other method(s) you used to interpret a patient's pharmacogenomic results. * Must be numeric Hidden unless: Question "Automatic alert via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: AA number Variable name: AA number 45 6. On average, how often do you encounter automatic alerts with pharmacogenomics-based recommendations via the electronic health record per week, approximately? * Must be numeric Hidden unless: Question "Digital pharmacogenomic report via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: DR_number Variable name: DR_number 42 7. On average, how many times do you use digital pharmacogenomic reports via the electronic health record to interpret a patient's pharmacogenomic results per week, approximately? * Must be numeric Hidden unless: Question "Paper-based pharmacogenomic report" is one of the following answers ("Yes") Shortname / Alias: PR_number Variable name: PR_number 43 8. On average, how many times do you use paper-based pharmacogenomic reports to interpret a patient's pharmacogenomic results per week, approximately? * Must be numeric Hidden unless: Question "Safety-code card" is one of the following answers ("Yes") Shortname / Alias: SC_number Variable name: SC_number 44 9. On average, how many times do you use the safety-code card to interpret a patient's pharmacogenomic results per week, approximately? *

Satisfaction with active CDS
Please rate how much you agree or disagree with the following statements about the automatic pharmacogenomic alerts.

Strongly disagree
Disagree Neutral Agree Strongly agree Must be numeric Hidden unless: Question "Other method(s)" is one of the following answers ("Yes") Shortname / Alias: OM_number Variable name: OM_number 49 10. On average, how many times do you use other methods to interpret a patient's pharmacogenomic results per week, approximately? * Hidden unless: Question "Automatic alert via the electronic health record" is one of the following answers ("Yes") 84 Hidden unless: Question "Automatic alert via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: AA_work_routine Variable name: AA_work_routine 71 11. They integrate well with my work routine. * Hidden unless: Question "Automatic alert via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: AA_userfriendliness Variable name: AA_userfriendliness 105 15. Overall, I would rate the user-friendliness of the automatic pharmacogenomic alerts as: * Hidden unless: Question "Automatic alert via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: AA_comments Variable name: AA_comments 51

Do you have any suggestions for improvement or other comments on the automatic pharmacogenomic alerts?
Hidden unless: Question "Digital pharmacogenomic report via the electronic health record" is one of the following answers ("Yes") 82 Hidden unless: Question "Digital pharmacogenomic report via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: DR_work_routine Variable name: DR_work_routine 72 17. They integrate well with my work routine. * Hidden unless: Question "Digital pharmacogenomic report via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: DR_training Variable name: DR_training 83 18. I feel that I have received enough training to confidently use them in my daily routine. * Hidden unless: Question "Digital pharmacogenomic report via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: DR_training Variable name: DR_training 112 19. Do you feel the digital pharmacogenomic reports provide you with too much, too little or just the right amount of information for use in clinical practice? *

Too little information
Just the right amount of information Hidden unless: Question "Digital pharmacogenomic report via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: DR_satisfaction Variable name: DR_satisfaction 53 20. Overall, how satisfied or dissatisfied are you with the digital pharmacogenomic reports in the electronic health record? * Hidden unless: Question "Digital pharmacogenomic report via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: DR_userfriendliness Variable name: DR_userfriendliness 107 21. Overall, I would rate the user-friendliness of the digital pharmacogenomic reports as: * Satisfaction with paper-based PGx reports Please rate how much you agree or disagree with the following statements about the paper-based pharmacogenomic reports:

Strongly disagree
Disagree Neutral Agree Strongly agree Hidden unless: Question "Digital pharmacogenomic report via the electronic health record" is one of the following answers ("Yes") Shortname / Alias: DR_comments Variable name: DR_comments 54 22. Do you have any suggestions for improvement or other comments on the digital pharmacogenomic reports in the electronic health record?
How do you like the structure of the report? Is the report too long? Is there any information that could be omitted in your opinion? Is there any information missing? Any other ideas for improvement?
Hidden unless: Question "Paper-based pharmacogenomic report" is one of the following answers ("Yes") 80 Hidden unless: Question "Paper-based pharmacogenomic report" is one of the following answers ("Yes") Shortname / Alias: PR_workroutine Hidden unless: Question "Paper-based pharmacogenomic report" is one of the following answers ("Yes") Shortname / Alias: PR_training Variable name: PR_training 81 24. I feel that I have received enough training to confidently use them in my daily routine. * Hidden unless: Question "Paper-based pharmacogenomic report" is one of the following answers ("Yes") Shortname / Alias: PR_information Variable name: PR_information 113 25. Do you feel the paper-based pharmacogenomic reports provide you with too much, too little or just the right amount of information for use in clinical practice? *

Too little information
Just the right amount of information Too much information Hidden unless: Question "Paper-based pharmacogenomic report" is one of the following answers ("Yes") Shortname / Alias: PR_satisfaction Variable name: PR_satisfaction 56 26. Overall, how satisfied or dissatisfied are you with the paper-based pharmacogenomic reports? *